The European Commission ( EC ) has extended approval for Rinvoq ( Upadacitinib ) 15 mg to treat adult patients with active psoriatic arthritis and adult patients with active ankylosing spondylitis.

The European Commission based its decision on data from the SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1 clinical trials.
In the phase 3 SELECT-PsA 1 and SELECT-PsA 2 trials, Upadacitinib met the primary endpoint, ACR20 response at week 12 compared with placebo, in adults with active PsA who demonstrated an inadequate response to non-biologic or biologic DMARDs.
In addition, the drug achieved noninferiority to Adalimumab ( Humira ), 40 mg administered every other week, regarding the ACR20 response at week 12.

SELECT-PsA 1

SELECT-PsA 1 is a phase 3, multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study designed to evaluate the safety and efficacy of Upadacitinib compared to placebo and Adalimumab in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic DMARD.
Patients were randomized to Upadacitinib 15 mg, Upadacitinib 30 mg, Adalimumab 40 mg EOW or placebo at baseline. At week 24, placebo patients were switched to either Upadacitinib 15 mg or Upadacitinib 30 mg.

The primary endpoint was the percentage of subjects receiving Upadacitinib 15 mg or Upadacitinib 30 mg who achieved an ACR20 response at 12 weeks of treatment versus placebo.
Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16 and proportion of patients achieving minimal disease activity ( MDA ) at week 24.

SELECT-PsA 2

SELECT-PsA 2 is a phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of Upadacitinib in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one biologic ( bDMARD ).
Patients were randomized to Upadacitinib 15 mg, Upadacitinib 30 mg or placebo followed by either Upadacitinib 15 mg or Upadacitinib 30 mg at week 24.

The primary endpoint was the percentage of subjects achieving an ACR20 response after 12 weeks of treatment.
Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16, as well as proportion of patients achieving MDA at week 24.

SELECT-AXIS 1

SELECT-AXIS 1 is a phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of Upadacitinib in adult patients with active ankylosing spondylitis who are bDMARD-naïve and had inadequate response to at least two NSAIDs or intolerance to/contraindication for NSAIDs.

Key ranked secondary endpoints included proportion of subjects achieving Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) 50 and ASAS partial remission ( PR ) at week 14, as well as change from baseline in Ankylosing Spondylitis Disease Activity Scores ( ASDAS ), MRI Spondyloarthritis Research Consortium of Canada ( SPARCC ) score ( spine ) and Bath Ankylosing Spondylitis Functional Index ( BASFI ) at week 14.
Period 2 is an open-label extension period to evaluate the long-term safety, tolerability and efficacy of Upadacitinib in subjects who completed Period 1. ( Xagena_2021 )

Source: Abbvie, 2021

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